510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780134Substantially Equivalent

Urinary Drainage Monitoring System

Medical Devices Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780134 is the FDA 510(k) clearance record for URINARY DRAINAGE MONITORING SYSTEM, a class II device, cleared for Medical Devices, Inc. on under FDA product code FCN (Urinary Drainage Collection Kit, For Indwelling Catheter). FDA records list 49 510(k) clearances for Medical Devices, Inc., from to . As of , FDA records show no recalls naming K780134.

Clearance record

Decision date
Received
(9 days to decision)
Product code
FCN Urinary Drainage Collection Kit, For Indwelling Catheter
Regulation
21 CFR 876.5250
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medical Devices, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FCN

Trailing 12 months

FDA records hold no clearances under product code FCN in the trailing twelve months.

FDA records show no clearances under product code FCN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260